check_circleStudy Completed
Magnetic Resonance Imaging, Magnetic Resonance Angiography
Bayer Identifier:
14823
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected patients
Trial purpose
Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients
Key Participants Requirements
Sex
BothAge
0 - N/ATrial summary
Enrollment Goal
23775Trial Dates
July 2010 - April 2013Phase
N/ACould I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Taiwan | |
Completed | Many Locations, Poland | |
Completed | Many Locations, South Africa | |
Completed | Many Locations, Italy | |
Completed | Many Locations, Hungary | |
Completed | Many Locations, Kazakhstan | |
Completed | Many Locations, Korea, Republic Of | |
Completed | Many Locations, Hong Kong | |
Completed | Many Locations, Russia | |
Completed | Many Locations, China | |
Completed | Many Locations, Thailand | |
Completed | Many Locations, Bosnia And Herzegovina | |
Completed | Many Locations, France | |
Completed | Many Locations, Greece | |
Completed | Many Locations, Vietnam | |
Completed | Many Locations, Czech Republic | |
Completed | Many Locations, Spain | |
Completed | Many Locations, Canada | |
Completed | Many Locations, Germany | |
Completed | Many Locations, Kyrgyzstan |
Primary Outcome
- Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroupsdate_rangeTime Frame:1 dayenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered.date_rangeTime Frame:1 dayenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A